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FDA 510(k)

Cannulated Screw

K-Number: K161058 · 2016-07-29

ApplicantMiami Device Solutions, LLC
Decision Date2016-07-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cannulated Screw is a medical device manufactured by Miami Device Solutions, LLC. It received FDA 510(k) clearance on 2016-07-29 under approval number K161058. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cannulated Screw?

Cannulated Screw is a medical device that received FDA 510(k) clearance on 2016-07-29. It is manufactured by Miami Device Solutions, LLC. The 510(k) number is K161058.

When was Cannulated Screw approved by the FDA?

Cannulated Screw received FDA 510(k) clearance on 2016-07-29, under approval number K161058.

What company makes Cannulated Screw?

Cannulated Screw is manufactured by Miami Device Solutions, LLC.

What is the FDA product code for Cannulated Screw?

The FDA product code for Cannulated Screw is HWC. This falls under the Cardiovascular category.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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